Actively Recruiting
Safety and Efficacy of Sequential Hormone Therapy and IBI311 Treatment for Active Moderate to Severe Thyroid-Associated Ophthalmopathy
Led by Shanghai Changzheng Hospital · Updated on 2025-09-03
64
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Thyroid-associated ophthalmopathy (TAO) is an autoimmune disease linked to thyroid problems, commonly seen in adults with Graves disease. TAO can cause complex symptoms affecting vision and daily life, sometimes leading to severe eye damage. This trial evaluates the safety and effectiveness of two treatments, IBI311, a monoclonal antibody targeting the IGF-1 receptor, and sequential hormone therapy, in patients with active moderate to severe TAO who have not been treated with glucocorticoids before. Participants will receive either IBI311 through 8 infusions (10 mg/kg initially, then 20 mg/kg for the remaining 7) or glucocorticoid therapy with 500 mg methylprednisolone injected intravenously daily for 3 days, followed by infusions every 2 weeks for a total of 8 treatments. The study compares these two treatments head-to-head during the initial treatment phase. During the trial, patients will be monitored up to 24 weeks for treatment responses including changes in clinical activity score, diplopia, proptosis, and overall improvement. Safety will be observed over about one year, tracking any treatment-related side effects. Quality of life and visual field changes will also be assessed. The study spans from screening through treatment and follow-up, with careful safety and efficacy measurements.
CONDITIONS
Brief Title
The Safety and Efficacy of Sequential Hormone Therapy and IBI311 Therapy in Patients With Active Moderate to Severe TAO in the Initial Treatment.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with thyroid-associated ophthalmopathy (TAO) by Bartley criteria
- Moderate to severe TAO defined by EUGOGO
- Clinical activity score (CAS) of 4 or higher on the 7-item scale for the study eye
- No prior glucocorticoid treatment for TAO
You will not qualify if you...
- Need for immediate intervention due to sight-threatening complications or rapid vision deterioration
- Presence of other orbital lesions
- Previous orbital radiotherapy or surgery for thyroid eye disease, including decompression, strabismus surgery, or eyelid correction
- History of tinnitus, hearing impairment, or abnormal audiometry results
- Elevated liver enzymes (AST or ALT greater than 3 times upper limit of normal) or active hepatitis B
- Glomerular filtration rate (GFR) less than 30 ml/min/1.73m2
- Poorly controlled diabetes or recent changes in diabetes medication
- Poorly controlled hypertension or recent changes in antihypertensive treatment
- Abnormal ECG findings affecting heart rate or rhythm
- Positive HIV, hepatitis C, or active syphilis infection
- Prior systemic steroid use for TAO
- Major illnesses or unstable conditions increasing risk or affecting study assessments
- Any condition impairing ability to follow study procedures or interpret data
- Pregnant or lactating
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants receive sequential hormone therapy and IBI311 therapy for active moderate to severe thyroid-associated ophthalmopathy.
8 infusion visits over 24 weeks
Trial Site Locations
Total: 2 locations
1
Shanghai Changzheng Hospital
Changhua, Shanghai Municipality, China, 200003
Actively Recruiting
2
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China, 200003
Not Yet Recruiting
Research Team
T
Tuo Li, Vice Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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